Hypertension in Pregnancy, Preeclampsia
Conditions
Keywords
Near-infrared spectroscopy (NIRS), Preeclampsia, Pregnancy
Brief summary
The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. The investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.
Detailed description
Maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (SMM/MM). The lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological SMM/MM. Impaired cerebral autoregulation may be such a biomarker. Preliminary results using transcranial Doppler (TCD) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. However, TCD is operator dependent, and cannot be used for extended monitoring due to discomfort. In contrast, near-infrared spectroscopy (NIRS) is fully automated and can be continued for hours at the bedside. Identifying personalized blood pressure (BP) targets using NIRS has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. However, this method has not been applied in postpartum women. This is a single center feasibility study that will include up to 10 women. Postpartum women admitted to the obstetrics high-risk stepdown unit for management of postpartum hypertension will be eligible for this study. Informed consent will be obtained from participants prior to enrollment in the study.
Interventions
None listed
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Columbia University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who have given birth within the previous 12 weeks * Admitted to the high-risk inpatient obstetrics unit for management of hypertension * With headache or other neurological symptoms such as vision changes
Exclusion criteria
* Acute ischemic stroke * Intracerebral or subarachnoid hemorrhage * Eclamptic seizures * Any other neurological complication requiring transfer to the neurological intensive care unit or stroke stepdown unit * History of Reynaud's syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenated hemoglobin concentration | Continuously collected for up to 24 hours | The Edwards HemoSphere system with ForeSight Elite NIRS component (Edwards LifeSciences) will be used to monitor oxygenated and deoxygenated hemoglobin concentrations. Two adhesive NIRS probes will be placed on the frontotemporal scalp covering the cortex, usually supplied by the middle cerebral artery. \[Describe how the concentration will be obtained, the range of anticipated concentrations, and how to interpret the concentrations - eg, higher concentrations indicate ...\] |
| Deoxygenated hemoglobin concentration | Continuously collected for up to 24 hours | The Edwards HemoSphere system with ForeSight Elite NIRS component (Edwards LifeSciences) will be used to monitor oxygenated and deoxygenated hemoglobin concentrations. Two adhesive NIRS probes will be placed on the frontotemporal scalp covering the cortex, usually supplied by the middle cerebral artery. |
| Blood pressure (BP) | Continuously collected for up to 24 hours | Continuous non-invasive BP monitoring will be utilized (ClearSight finger cuff system, Edwards LifeSciences). |
Countries
United States
Outcome results
None listed